The Celerity System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

Atrial fibrillation
Atrial flutter
Severe tachycardia
Pacemaker-Driven Rhythm
Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional method is necessary to confirm catheter tip location.

Device Description

The Celerity™ ECG Cable Accessory Pack consists of a sterile remote cover and a specialized alligator PICC clip. The Celerity™ ECG Cable Accessory Pack is designed to be used in conjunction with the Celerity™ System to provide a continuous display of electrocardiograph waveforms to guide placement of peripherally-inserted central catheters in the patient's right atrium of the heart.

AI/ML Overview

This document describes the Celerity™ ECG Cable Accessory Pack, an accessory product used with the Celerity™ System for positioning Peripherally Inserted Central Catheters (PICC). The primary purpose of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (K142889).

Here's an analysis of the provided information, focusing on the requested criteria:

1. A table of acceptance criteria and the reported device performance

Based on the provided regulatory document, the acceptance criteria are primarily focused on demonstrating substantial equivalence to the predicate device K142889 for an accessory pack consisting of an ECG cable and remote cover. The performance reported is that the accessory pack does not raise new or different questions of safety and effectiveness and performs identically to the predicate device's components.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Indications for Use	Identical indications for use as the predicate device (K142889): Positioning of PICC in adult patients using cardiac electrical activity as an alternative to chest x-ray/fluoroscopy.	Identical: The Celerity ECG Cable Accessory Pack has the same indications for use as the predicate (K142889) and supports the Celerity System to function as described.
Intended Use	Identical intended use as the predicate device (K142889).	Identical: The intended use of conducting an ECG signal from the PICC stylet to the Celerity remote control to provide real-time tip location is the same.
Target Population	Identical target population (adults 18 years or older) as the predicate device (K142889).	Identical: Intended for use in adults (18 years or older).
Design	The accessory pack, consisting of a sterile remote cover and a specialized alligator PICC clip, must function in conjunction with the Celerity™ System to provide continuous ECG waveforms.	Components function as intended: The accessory pack's components are designed to be used with the Celerity System for ECG waveform display and PICC placement guidance.
Materials	Materials for the ECG Clip Cable (nickel plated steel, PVC, nylon, polyethylene, gold/nickel plated contacts) and Remote Cover (latex-free polyethylene) are consistent with the predicate.	Identical Materials: The materials used for the ECG Clip Cable and Remote Cover are stated to be the same as those in the predicate device.
Sterilization Method	Identical sterilization method (Ethylene Oxide) as the predicate device (K142889).	Identical: Ethylene Oxide sterilization method is used, matching the predicate.
Safety and Effectiveness	Does not raise new or different questions of safety and effectiveness compared to the predicate device.	Demonstrated through Non-Clinical Testing: Bench/performance/non-clinical testing (aging, equipment interaction, shipping) was conducted to support this claim. Biocompatibility not applicable.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench/performance/non-clinical testing for an accessory pack, not a clinical study involving patients. Therefore, traditional "test set" and "data provenance" as applied to clinical data are not fully applicable here.

Sample size for non-clinical testing: The document does not specify exact sample sizes for each test listed (e.g., how many alligator clips were subjected to accelerated aging). It lists the types of tests performed.
Data Provenance: The data provenance is from internal non-clinical testing conducted by the manufacturer, Medical Components, Inc. (dba Medcomp®). No country of origin is explicitly stated for the testing, but the manufacturer is based in Harleysville, Pennsylvania, USA, implying the testing likely occurred in the USA or through US-based labs. The tests are non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the submission is for an accessory pack and relies on non-clinical, bench testing to demonstrate substantial equivalence. There is no clinical "test set" requiring expert ground truth establishment in the context of diagnostic accuracy. The ground truth for the non-clinical tests would be defined by engineering specifications and standards for electrical conductivity, material integrity, and aging performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. Since there is no clinical test set requiring human interpretation or diagnosis, there is no need for an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is an ECG cable accessory pack, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical accessory pack that facilitates the existing Celerity System's ECG-based tip confirmation technology. It does not involve a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical testing conducted, the "ground truth" would be objective engineering and performance specifications. For example:

Functional performance: The ability of the alligator clips and remote cover to conduct an ECG signal accurately and reliably.
Durability/Aging: Ability to withstand accelerated aging simulation for 1 and 3 years without compromising function or integrity.
Shipping Integrity: Ability of the packaged accessory pack to withstand shipping stresses (ISTA 2A).
Material Composition: Conformance to specified material compositions.

These "ground truths" are established by engineering standards and internal quality control, not by expert clinical consensus, pathology, or outcomes data, as this is a non-clinical submission for an accessory.

8. The sample size for the training set

This section is not applicable. This submission is for a physical accessory product and describes non-clinical testing to demonstrate substantial equivalence to a predicate. There is no machine learning or AI component requiring a "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as point 8.

Summary

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October 26, 2017

Medical Components, Inc. (dba Medcomp®) Colton Muraira Regulatory Affairs 1499 Delp Dr. Harleysville, Pennsylvania 19438

Re: K171931

Trade/Device Name: Celerity™ ECG Cable Accessory Pack Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: LJS Dated: September 15, 2017 Received: September 26, 2017

Dear Colton Muraira:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Tina Kiang
S

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K171931

Device Name

Celerity ECG Cable Accessory Pack

Indications for Use (Describe)

Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

· Atrial fibrillation
· Atrial flutter
· Severe tachycardia
· Pacemaker-driven rhythm
· Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional confirmation method is necessary to confirm catheter tip location.

Type of Use (Select one or both, as applicable)

× | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K171931 510(K) SUMMARY

Manufacturer's Name:	Medical Components, Inc. (dba Medcomp®)1499 Delp DriveHarleysville, PA 19438
Corresponding Official:	Colton MurairaRegulatory: North America and EU
Telephone Number:	(215) 256-4201, x 2285
Email:	CMuraira@Medcompnet.com
Preparation Date:	October 23, 2017
Trade Name:	Celerity™ ECG Cable Accessory Pack
Common or Usual Name:	PICC Placement Accessory
Regulation Name:	Percutaneous, implanted, long-termintravascular catheter
Regulation Number:	21 CFR 880.5970
Product Code:	LJS
Device Class:	Class II
Primary Predicate Device:	K142889 - AngioDynamics Inc. Celerity™ PICC Tip ConfirmationSystem

Device Description:

Indications For Use

The Celerity™ System is indicated for the positioning of Peripherally Inserted Central Catheters (PICC) in adult patients. It provides real-time catheter tip location information by using the patient's cardiac electrical activity. The Celerity System is indicated for use as an alternative method to chest x-ray or fluoroscopy confirmation of PICC tip placement in adult patients.

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Note: In general, devices that utilize ECG technique to observe P-wave are limited, but not contraindicated for patients where cardiac rhythms may change presentation of the P-wave; including:

। Atrial fibrillation
Atrial flutter -
-Severe tachycardia
Pacemaker-Driven Rhythm -
-Chronic obstructive pulmonary disease (COPD)

Such patients are easily identified prior to PICC insertion. Use of an additional method is necessary to confirm catheter tip location.

Substantial Equivalence Discussion

The subject device is an accessory pack to the Celerity System. The subject device accessory pack consists of a sterile remote cover and a specialized alligator PICC clip. Both devices use changes in cardiac electrical activity to provide real-time catheter tip location.

Celerity™ ECG Cable Accessory Pack has been compared to the cleared "Celerity™ PICC Tip Confirmation System" (510(k)# K142889) as a reference for substantial equivalence. A table comparing the two devices is provided as follow:

Attribute	Subject Device – K171931:Celerity ECG Cable AccessoryPack	Predicate Device – K142889 :Celerity PICC Tip ConfirmationSystem	Comparison
510(k) Holder	Medcomp, Inc	AngioDynamics	N/A
Design	The Celerity ECG CableAccessory Pack is designed to beused in conjunction with theCelerity™ System to provide acontinuous display ofelectrocardiograph [ECG]waveforms to guide placement ofperipherally-inserted centralcatheters [PICC] in the patient'sright atrium of the heart.Sterile remote cover: covers asufficient length of the remotecontrol cable to provide a sterilebarrier capable of being pierced bythe remote control PICCconnector.Sterile PICC Clip Connector:	The Celerity PICC TipConfirmation System is anaccessory to peripherally-insertedcentral catheters (PICC). It aids aclinician in placing PICCoptimally, in the superior venacava near the entrance to the rightatrium of the heart.	ComponentsSame
	Capable of conducting an ECGsignal from the PICC stylet to theCelerity remote control.	To provide real time tip locationinformation of a central venouscatheter by utilization of ECG toobserve P-wave changes as the tipapproaches the right atrium of theheart via the superior vena cava.	To provide real time tip locationinformation of a central venouscatheter by utilization of ECG toobserve P-wave changes as the tipapproaches the right atrium of theheart via the superior vena cava.	Same
Intended use
Indications foruse	The Celerity ECG CableAccessory Pack is indicated for thepositioning of PeripherallyInserted Central Catheters (PICC)in adult patients. It provides real-time catheter tip locationinformation by using the patient'scardiac electrical activity. TheCelerity System is indicated foruse as an alternative method tochest x-ray or fluoroscopyconfirmation of PICC tipplacement in adult patients.Note: In general, devices thatutilize ECG technique to observeP-wave are limited, but notcontraindicated for patients wherecardiac rhythms may changepresentation of the P-wave;including:- Atrial fibrillation- Atrial flutter- Severe tachycardia- Pacemaker-Driven Rhythm- Chronic obstructivepulmonary disease (COPD)Such patients are easily identifiedprior to PICC insertion. Use of anadditional method is necessary toconfirm catheter tip location.	The Celerity System is indicatedfor the positioning of PeripherallyInserted Central Catheters (PICC)in adult patients. It provides real-time catheter tip locationinformation by using the patient'scardiac electrical activity. TheCelerity System is indicated foruse as an alternative method tochest x-ray or fluoroscopyconfirmation of PICC tipplacement in adult patients.Note: In general, devices thatutilize ECG technique to observeP-wave are limited, but notcontraindicated for patients wherecardiac rhythms may changepresentation of the P-wave;including:- Atrial fibrillation- Atrial flutter- Severe tachycardia- Pacemaker-Driven Rhythm- Chronic obstructivepulmonary disease (COPD)Such patients are easily identifiedprior to PICC insertion. Use of anadditional method is necessary toconfirm catheter tip location.	Same
TargetPopulation	Adults (18 years or older)	Adults (18 years or older)	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide	Same
Materials	ECG Clip Cable: nickel platedsteel with a white PVC insulator.The audio connector consists of anylon and polyethylene insulatorand gold or nickel plated contactsRemote Cover: latex-freepolyethylene	ECG Clip Cable: nickel platedsteel with a white PVC insulator.The audio connector consists of anylon and polyethylene insulatorand gold or nickel plated contactsRemote Cover: latex-freepolyethylene	Same

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The indications for use statement and the intended use of the subject device are identical to the predicate device. The differences between the subject device and the predicate device are:

1. Proposed device is an accessory pack containing separate components to be used with the predicate Celerity System, which already contains stated components.
1. Different manufacturer of the ECG Clip Cable and Remote Cover

Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.

Bench/Performance/Non-Clinical Testing

The following testing was conducted to demonstrate substantial equivalence of the Celerity™ ECG Cable Accessory Pack to the predicate devices:

Item	Test Name
1	Alligator Clips – 1 year accelerated aging
2	Alligator Clips – 3 year accelerated aging
3	Equipment Interaction of Alligator Clips,ECG Electrodes, and ECG Snap Leads
4	Probe Cover – 1 year accelerated aging
5	Celerity Accessory Pack – 1 year accelerated aging
6	Celerity Accessory Pack – 3 year accelerated aging
7	Celerity Accessory Packs – ISTA 2A Shipping Test

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Biocompatibility

The subject device is non-patient contacting and therefore, biocompatibility testing is not applicable.

Conclusion

The modifications to the subject device include the change of the manufacture of the ECG Clip Cable and the Remote Cover and the packaging of the ECG Clip Cable and Remote Cover as an accessory pack. The modifications do not raise new or different questions of safety and effectiveness and are supported by non-clinical testing.

The Celerity ECG Cable Accessory Pack is substantially equivalent to the Celerity PICC Tip Confirmation System cleared under K142889.

Regulation Number and Section

§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.

(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”